Company |
Product |
Description |
Indication |
Status |
Date |
AUTOIMMUNE | |||||
Ablynx NV (Ghent, Belgium) |
ALX-0061 |
Anti-IL-6R nanobody |
Moderate to severe active rheumatoid arthritis |
Met the efficacy endpoint of a significant improvement in key indicators of disease activity in the Phase I/II study |
10/5/12 |
Protalex Inc. (Summit, N.J.) |
PRTX-100 |
A highly purified form of Protein A |
Rheumatoid arthritis |
Phase Ib data showed it was safe and well tolerated at all dose levels, and that more patients in the higher-dose cohorts showed improvement in their clinical disease activity index than patients in the lower-dose or placebo cohorts |
10/19/12 |
TxCell SA (Valbonne, France) |
Ovasave |
An antigen-specific regulatory T-cell-based immunotherapy |
Crohn's disease |
Phase I/II data showed a good tolerability profile and an apparent dose-related effect |
10/25/12 |
XenoPort Inc. (Santa Clara, Calif.) |
XP23829 |
A fumaric acid ester compound that is a prodrug of monomethyl fumarate |
Relapsing-remitting multiple sclerosis and/or psoriasis |
Phase I data showed that administration of XP23829 resulted in expected levels of MMF in the blood |
10/8/12 |
CANCER | |||||
Actinium Pharmaceuticals Inc. (New York) |
Actimab-A |
Antibody-directed alpha-emitter drug candidate |
Front-line acute myeloid leukemia |
Phase I data showed it demonstrated significant antileukemic activity across all dose levels |
10/11/12 |
Aduro BioTech Inc. (Berkeley, Calif.) |
CRS-207 |
A therapeutic cancer vaccine |
Newly diagnosed with malignant pleural mesothelioma |
Enrolled the first patient in a Phase Ib study |
10/3/12 |
Cleveland BioLabs Inc. (Buffalo, N.Y.) |
CBL0137 |
Oral formulation |
Advanced solid tumors |
The first patient was dosed in a Phase I single-agent, dose-escalation trial |
10/11/12 |
Curis Inc. (Lexington, Mass.) |
CUDC-101 |
Oral formulation; small-molecule designed to inhibit histone deacetylase, epidermal growth factor receptor and epidermal growth factor receptor 2 |
Advanced and refractory solid tumors |
The first patient was treated in a Phase I study |
10/3/12 |
CytRx Corp. (Los Angeles) |
Aldoxorubicin |
Formerly INNO-206; tumor targeting doxorubicin conjugate aldoxorubicin |
Metastatic solid tumors |
Started a Phase Ib trial |
10/16/12 |
Galena Biopharma Inc. (Lake Oswego, Ore.) |
NeuVax |
Nelipepimut-S or E75 |
Breast cancer |
Phase I/II data showed it decreased circulating tumor cells in 16 of 26 breast cancer patients during vaccine treatment |
10/29/12 |
Immunovaccine Inc. (Halifax, Nova Scotia) |
DPX-Survivac |
An ovarian cancer vaccine |
Ovarian cancer |
Phase I data showed all nine patients receiving the vaccine in combination with low-dose oral cyclophosphamide produced a targeted immune response following only one or two vaccine administrations |
10/11/12 |
Novelos Therapeutics Inc. (Madison, Wis.) |
I-124-CLR1404 |
Cancer-targeted positron emission tomography imaging agent |
Solid tumors |
Enrolled the first patient in a Phase I/II trial |
10/26/12 |
OncoMed Pharmaceuticals Inc. (Redwood City, Calif.) |
OMP-59R4 |
Anti-Notch2/3 antibody |
Advanced pancreatic cancer |
Started a Phase Ib/II trial |
10/5/12 |
Orexo AB (Uppsala, Sweden) |
OX51 |
A sublingual formulation of alfentanil |
For patients undergoing prostate biopsy |
Began a dose-finding study |
10/31/12 |
Vaximm AG (Basel, Switzerland) |
VXM01 |
Oral therapeutic cancer vaccine |
Inoperable pancreatic cancer |
Completed enrollment in a Phase I/II dose-escalation study |
10/23/12 |
CARDIOVASCULAR | |||||
AlphaCore Pharma Inc. (Ann Arbor, Mich.) |
ACP-501 |
Recombinant human LCAT |
Atherosclerosis |
Phase I trial met the primary endpoint by demonstrating safety and tolerability and also met secondary endpoints by rapidly and substantially elevating HDL cholesterol |
10/10/12 |
Arena Pharmaceuticals Inc. (San Diego) |
APD811 |
An oral drug that targets the prostacyclin receptor |
Pulmonary arterial hypertension |
Started dosing in a Phase I trial |
10/15/12 |
Canyon Pharmaceuticals Inc. (Parsippany, N.J.) |
Desirudin |
Revasc, Iprivask; direct thrombin inhibitor |
To prevent blood clots |
Results from an open-label, single-arm study showed it demonstrated clinical utility and safety |
10/11/12 |
Cytori Therapeutics Inc. (San Diego) |
Cell therapy |
Patients have adipose tissue removed that is then used for processing into adipose-derived stem and regenerative cells |
Refractory heart failure resulting from myocardial ischemia |
Began a Phase I/II trial |
10/12/12 |
MicroDose Therapeutx Inc. (Monmouth Junction, N.J.) |
MDT-637 |
Inhaled antiviral fusion inhibitor |
Respiratory syncytial virus |
Completed its third and final Phase I study |
10/1/12 |
Thrombolytic Science International LLC (Cambridge, Mass.) |
TS01 |
A new-generation clot-dissolving therapy |
Acute ischemic stroke |
Started a Phase I study |
10/3/12 |
CENTRAL NERVOUS SYSTEM | |||||
Neuralstem Inc. (Rockville, Md.) |
NSI-189 |
A small molecule designed to stimulate new neuron growth in the hippocampus |
Major depressive disorder |
Started dosing in the second cohort of patients in its Phase Ib trial |
10/18/12 |
DIABETES | |||||
Aerpio Therapeutics Inc. (Cincinnati) |
AKB-9778 |
Human protein tyrosine phosphatase-beta inhibitor |
Diabetic macular edema |
Moved into a Phase IB/IIa study |
10/5/12 |
Diartis Pharmaceuticals Inc. (Mountain View, Calif.) |
VRS-859 |
Exenatide-XTEN; a long-acting glucagon-like peptide-1 analogue |
Type II diabetes |
Phase I data showed it was well tolerated in repeated dosings of 200 mg per month; it also had statistically significant reductions in HbA1c levels at 30 days after a single dose |
10/3/12 |
Rhythm Pharmaceuticals Inc. (Boston) |
RM-131 |
A ghrelin agonist |
Diabetic gastroparesis |
Phase I data demonstrated greatly accelerated gastric emptying in healthy subjects |
10/23/12 |
INFECTION | |||||
Fab'entech (Lyon, France) |
Unnamed |
Polyclonal immunoglobulin product |
H5N1 avian flu virus |
Company is launching a Phase I trial |
10/16/12 |
Genticel SA (Toulouse, France) |
ProCervix, |
A vaccine for HPV16 and HPV18 |
Human papillomavirus |
Phase I data showed it was safe and well tolerated at the highest dose, and that there were HPV-E7-antigen-specific T-cell responses in a majority of vaccinated women |
10/19/12 |
Inovio Pharmaceuticals Inc. (Blue Bell, Pa.) |
VGX-3100 |
Therapeutic synthetic vaccine |
Human papillomavirus infection |
Phase I data indicated it was capable of not only driving robust immune responses to antigens from high-risk types of infection, but showed a powerful killing effect on cells changed by HPV into precancerous dysplasias |
10/12/12 |
Methylgene Inc. (Montreal) |
MGCD290 |
An antifungal compound |
Fungal infection |
Phase I data showed all doses were tolerated with no severe or serious adverse events |
10/23/12 |
Novavax Inc. (Rockville, Md.) |
Vaccine |
A/H5N1 avian influenza vaccine candidate |
Avian influenza |
Top-line Phase I data showed it was safe and produces immunogenicity with and without adjuvant |
10/19/12 |
Novavax Inc. (Rockville, Md.) |
RSV-F |
Nanoparticle protein micelle vaccine candidate with and without aluminum phosphate as an adjuvant |
Respiratory syncytial virus |
Started enrollment in a Phase I trial |
10/17/12 |
MISCELLANEOUS | |||||
Histogen Inc. (San Diego) |
HSC |
Hair Stimulating Complex |
For hair growth |
Phase I/II data showed it produced statistically significant improvement across all targeted hair growth parameters |
10/22/12 |
Civitas Therapeutics Inc. (Chelsea, Mass.) |
CVT-301 |
An inhaled levodopa (L-dopa) formulation |
To manage motor fluctuations caused by interdose variability of oral L-dopa |
Phase I data showed inhaled delivery achieved therapeutic L-dopa plasma levels within five minutes of administration with consistent and dose proportional pharmacokinetics seen across all doses |
10/16/12 |
Hadasit Bio-Holdings Ltd. (Jerusalem) |
ApoCell |
Cellular treatment |
Graft-vs.-host disease |
Completed a 13-patient clinical trial, with results indicating efficacy and safety in recipients of bone marrow transplants from foreign donors |
10/25/12 |
Oculus Innovative Sciences Inc. (Petaluma, Calif.) |
Atrapro |
Microcyn technology-based; antipruritic hydrogel |
Atopic dermatitis |
Open-label pilot study of the hydrogel in combination with Neosalus cream demonstrated a statistically significant 50% reduction in the body surface area of the atopic dermatitis from baseline to week four |
10/10/12 |
Onconova Therapeutics Inc. (Newtown, Pa.) |
Ex-RAD |
Recilisib sodium |
Acute radiation syndrome |
Phase I data showed it was rapidly absorbed and well tolerated, without clinically significant drug-related systemic toxicity |
10/5/12 |
StemCells Inc. (Newark, Calif.) |
HuCNS-SC |
Purified human neural stem cells |
Dry age-related macular degeneration |
First patient was enrolled in its Phase I/II study |
10/5/12 |
Summit plc (Oxford, UK) |
SMT C1100 |
Designed to be a potentially disease-modifying drug that works to increase or up-regulate the amount of utrophin in patients with DMD |
Duchenne's muscular dystrophy |
Phase I data showed the study met its primary endpoints |
10/11/12 |
Synergy Pharmaceuticals Inc. (New York) |
SP-333 |
Second-generation guanylate cyclase C receptor analogue |
Ulcerative colitis |
Began oral dosing of healthy volunteers in its Phase I trial |
10/23/12 |
Versartis Inc. (Redwood City, Calif.) |
VRS-317 |
A once-monthly form of recombinant human growth hormone |
Growth hormone deficiency |
Started its first pediatric trial, a Phase Ib/IIa study |
10/25/12 |
|
Notes: Public biotech company stock symbols can be found in the stock report located on the last two pages of this issue. The date indicated refers to the BioWorld Today issue in which the news item can be found. | |||||